Investigation of the Effects of Dietary Fibres on the Gut Microbiome in a Transgenerational Cohort

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Imperial College London

Status

Completed

Conditions

Gut Health

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Dietary Fibres Mix

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05364437
20HH5806

Details and patient eligibility

About

Dietary fibres are complex carbohydrates present in fruit, vegetables, grains, and beans which are broken down into smaller molecules (short-chain fatty acids) in the colon by the gut microbiota. Increased intake of dietary fibres is associated with a lower risk of type 2 diabetes, obesity, or heart disease. Despite their health benefits, most people consume half of the daily recommended intake (30 grams) of dietary fibres. This trend has become more apparent in the past few decades with the advent of ultra-processed foods which are poor in dietary fibres. Since this change in dietary habits is more recent, the research team hypothesizes that older generations have a more diverse and better adapted gut microbiota at breaking down dietary fibres compared to younger generations. The aims of this study are to examine the effects of the daily intake over four weeks of a dietary fibres supplement on the gut microbiota, metabolic profiles, and general health in a transgenerational cohort (grandmother, mother and daughter OR mother and daughter) compared to placebo.

Full description

Eligible participants will need to take daily for 14 days a dietary fibre supplement or placebo (depending on the randomisation) followed by wash-out period of 14 days and then followed by taking daily for 14 days the opposite arm of intervention (placebo or dietary fibre supplement). During the study period, participants will come to the research facility to assess the impact of these supplements on their gut microbiota, metabolic profiles and blood glucose, insulin and gut hormone levels.

Enrollment

20 patients

Sex

Female

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Any of the following groups of people (in direct descent and from the same family) Grandmother, mother and daughter Mother and daughter Grandmother and granddaughter
  • Age 18-85 (inclusive)
  • BMI: 18.5-30 kg/m2 (inclusive)
  • Considering themselves healthy

Exclusion Criteria

  • Intake of antibiotics in the past 3 months and during the study
  • Intake of probiotic supplements in the past month and during the study
  • Regular intake of laxatives in the past month and during the study
  • Subjects with the following conditions Inflammatory Bowel Disease (IBD) Irritable Bowel Syndrome (IBS) Coeliac Disease Type 2 Diabetes Any type of cancer Autoimmune conditions Conditions that affect the liver Conditions that affect the pancreas
  • Subjects who require medical intervention in the coming 3 months
  • Smokers
  • Shift workers
  • Gluten and/or lactose intolerance
  • Pregnant and lactating women
  • Subjects living in care homes
  • had weight changes >5% in the preceding 3 months
  • Subjects who are unable to give informed consent by themselves
  • Subjects who are currently participating in other clinical trials

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

20 participants in 2 patient groups, including a placebo group

Dietary Fibres Supplement
Active Comparator group
Description:
Dietary fibre mix comprising of inulin, pectin and oat beta-glucan. The mix comes in a powdered form which can be added to participants' food.
Treatment:
Dietary Supplement: Dietary Fibres Mix
Placebo
Placebo Comparator group
Description:
Placebo comprising of cellulose which will come in a powdered form that can be added to participants' food.
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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